Point-of-Care Testing: Page 4

BioMĂ©rieux receives FDA CLIA waiver for multiplex PCR respiratory panel
By LabPulse.com staff writers
In about 15 minutes, the panel detects five of the most common viral causes of upper respiratory tract infections: SARS-CoV-2, influenza A, influenza B, respiratory syncytial virus (RSV), and rhinovirus.
May 11, 2023
Patient Doctor Women Social
Cue Health submits de novo request to FDA for at-home molecular RSV test
By LabPulse.com staff writers
Separately, Cue Health said it now offers over-the-counter and prescription medications for sexual health, birth control, hair loss, and more.
May 9, 2023
Cue Products Social
Stop using certain SD Biosensor Pilot COVID-19 At-Home Tests distributed by Roche Diagnostics, FDA says
By LabPulse.com staff writers
The FDA said in a warning notice published at its website on Thursday that it has significant concerns of bacterial contamination in the Pilot COVID-19 At-Home Test liquid solution provided in the test kit.
May 5, 2023
Man Hand Stop Social
Labcorp to partner with Jefferson Health on lab services
By LabPulse.com staff writers
Under the agreement, Labcorp will acquire some assets of Jefferson’s outreach laboratory services, while Jefferson will continue to own and operate its hospital labs for inpatient and outpatient services.
May 3, 2023
Patient Man Social
QuidelOrtho Q1 revenues drop with lower respiratory testing
By LabPulse.com staff writers
On a supplemental combined basis, first-quarter respiratory testing revenues, including COVID-19 testing, fell 72% year-over-year to $265.6 million from $947.3 million. Non-respiratory testing revenues rose 5% year-over-year.
May 3, 2023
Graph Financial Results Tablet Social
FDA issues draft guidance for implementing decentralized clinical trials
By LabPulse.com staff writers
This draft guidance builds on agency recommendations issued in 2020, which provided clarity for investigators to facilitate trial decentralization in response to the COVID-19 public health emergency.
May 2, 2023
Fda Button Social
Mainz Biomed partners with Instituto de Microecologia for at-home CRC test distribution in Spain, Portugal
By LabPulse.com staff writers
The Instituto de Microecologia in Madrid will partner with Mainz to market the CRC detection test to physicians and their patients in the Iberian Peninsula.
April 26, 2023
Colon2 Social
YourBio Health gets FDA clearance for device to collect capillary whole blood
By LabPulse.com staff writers
The firm has been developing technology for more than 15 years with the aim of enabling painless and remote blood collection.
April 24, 2023
Lab Blood Samples Social
Curative spins off Sensible Diagnostics to commercialize point-of-care PCR platform
By LabPulse.com staff writers
The spin-off is utilizing the experience Curative has gained with its diagnostics business during the pandemic, having run more than two million molecular point-of-care COVID-19 tests.
April 24, 2023
Blood Test Samples Lab Social
Mark Cuban Cost Plus Drug Company, Binx Health team up on testing, prescription medicine
By LabPulse.com staff writers
Through the collaboration, patients can access testing via Binx health’s digital platform and receive medication through the Cost Plus Drugs online prescription program.
April 24, 2023
Business Handshake Intelligence Social
Trinity Biotech selling life sciences supply business to Biosynth for $30M
By LabPulse.com staff writers
Trinity Biotech said it pursued the transaction as part of its plan to focus on diabetes care and decentralized monitoring and diagnostic solutions.
April 20, 2023
Business Deal Corporate Social
Point-of-care IVD sales rose to $45 billion in 2022
By Bruce Carlson
Numerous trends will combine to enable a growing market. According to the Kalorama report, growth of 3.3% per year is expected over the forecast period from 2022 to 2027.
April 19, 2023
3d Closeup Coronavirus Social
Previous Page
Page 4 of 41
Next Page